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Severing Nuchal Cord at the Time of Delivery.
This study has been completed.
Sponsored by: Wolfson Medical Center
Information provided by: Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT00345254
  Purpose

Umbilical cord often becomes encircled around portions of the fetus, usually the neck. The incidence ranges from 1 loop in 21% to 3 loops in 0.2%. In this study we wish to assessed the practice of severing the cord, which was encircled once around the neck of the fetus, after delivery of the anterior shoulder and prior to extraction of the body. The study and the control groups will include 30 women, each one. After diagnosis of cord around the neck during labor by ultrasound, the women will inter a randomization process. After delivery of the head, it will be cut intentionally in the study group and left intact in the control group. Neonatal outcome will be assessed.


Condition Intervention Phase
Umbilical Cord
Obstetric Delivery
Newborn Infant
Procedure: severing umbilical cord
Phase I

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Study That Clarifies Whether Cord Around the Neck Should Be Severed at Delivery.

Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • umbilical artery pH

Study Start Date: September 2003
  Eligibility

Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

single loop cord around the neck active labor spontaneous vaginal delivery

Exclusion Criteria:

instrumental delivery cesarean section false positive finding of cord around the neck multiple loop cord around the neck

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345254

Locations
Israel
Deliveery Ward, Edith Wolfson Medical Center,
Holon, Israel, 56100
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Oscar Sadan, MD E Wolfson Medical Center, Holon, Israel
  More Information

Study ID Numbers: OS-SL-001
Study First Received: June 26, 2006
Last Updated: June 26, 2006
ClinicalTrials.gov Identifier: NCT00345254  
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on February 06, 2009